Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

June 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

GUEST COLUMNISTS

Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
Let's Stop Treating Allogeneic Cell Therapy As One Thing
Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.
Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.
Building CGT Manufacturing Capacity For The Next Commercial Era
Recent investments — mostly by CDMOs — are expanding manufacturing capacity to support the growing cell and gene therapy pipeline. We also discuss associated trends and impacts.
Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.
Managing The Presence Of Visible Particulates In Cell Therapies
Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls.
Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program
In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

PHARMA OUTSOURCING WHITE PAPERS

The 5 Ws Of A Human Factors Strategy
A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

Modern Modeling Tools For Small Molecule Solid Dose Manufacturing
Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.
Analytical Approach For Bispecific Antibody Quality Study
Bispecific antibody quality control demands advanced analytics to detect mispaired species, assess structural integrity, and confirm potency, ensuring safety and efficacy across diverse therapeutic applications.
In Vivo Testing Of Nasal Dosage Forms
Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.
International Reference Pricing (IRP): Foundations, Shifts, And What To Do Next
As global pricing reforms evolve and policies gain traction, stakeholders must critically reassess the role of International Reference Pricing in balancing affordability, access, and incentives for innovation.
Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators
Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.